Graftless TSFE Via Self-tapping Implants (G-TSFE)

Sana'a University

Status: Enrolling

Conditions: Edentulous Posterior Maxilla; Maxillary Sinus Pneumatization; Alveolar Bone Atrophy

Treatments: Procedure: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07424742

OMFS:12/06/2024

Details and patient eligibility

About

This prospective clinical trial aims to evaluate the efficiency, safety, and reliability of a minimally invasive graftless transcrestal sinus lifting approach with simultaneous dental implant placement in patients with edentulous posterior maxilla and limited residual bone height.

The study investigates bone formation beneath the Schneiderian membrane, implant stability, osseointegration, and long-term implant survival.

Full description

This prospective clinical study evaluates a minimally invasive graftless sinus lifting technique using a transcrestal approach with simultaneous implant placement in the posterior maxilla.

The procedure involves tenting the Schneiderian membrane without the use of grafting material, relying on blood clot formation and natural bone regeneration beneath the elevated membrane.

Radiographic and clinical evaluations will be performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation, implant stability, and osseointegration.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18-80 years.
2. Patients with edentulous posterior maxilla.
3. Residual bone height approximately 4-6 mm.
4. Indicated for transcrestal sinus membrane elevation.
5. Good general health (ASA I or II).
6. Ability to provide written informed consent.
7. Willingness to attend follow-up visits.

Exclusion criteria

1. Severe systemic diseases (ASA III or above).
2. Uncontrolled diabetes mellitus.
3. Active sinus pathology.
4. History of radiotherapy in the head and neck region.
5. Heavy smokers (>10 cigarettes/day).
6. Pregnancy or lactation.
7. Untreated periodontal disease.

7. Poor oral hygiene.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement

Experimental group

Description:

Participants with edentulous posterior maxilla and residual bone height of approximately 5 mm will undergo minimally invasive graftless transcrestal sinus membrane elevation followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant.

Treatment:

Procedure: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement